Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT03866525

OH2 Oncolytic Viral Therapy in Solid Tumors

Led by Binhui Biopharmaceutical Co., Ltd. · Updated on 2024-12-20

300

Participants Needed

1

Research Sites

334 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase I/II study evaluates the safety and efficacy of OH2 as single agent or in combination with HX008, an anti-PD-1 antibody, in patients with malignant solid tumors (gastrointestinal cancers, head and neck cancers, soft tissue sarcomas). OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.

CONDITIONS

Official Title

OH2 Oncolytic Viral Therapy in Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed unresectable or recurrent/metastatic solid tumors.
  • Failed standard treatment due to disease progression or intolerable toxicity, or no standard treatment established.
  • Measurable disease based on RECIST 1.1.
  • ECOG Performance Status of 0 or 1.
  • Life expectancy greater than 3 months.
  • At least one tumor site suitable for intratumoral injection.
  • Adequate organ function.
  • Willingness to use contraception during the study and for 3 months after last dose if of reproductive potential.
  • History of HSV infection must be resolved at least 3 months before the study.
  • Able and willing to provide written informed consent and comply with study requirements.
Not Eligible

You will not qualify if you...

  • Uncontrolled concurrent illnesses including severe cardiac disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, active systemic infection, or active peptic ulcer disease.
  • Symptomatic central nervous system metastases.
  • Active infection or unexplained fever above 38.5 0C.
  • Known HIV infection or active Hepatitis B or C infection.
  • Pregnant or breastfeeding women.
  • Receiving other investigational agents.
  • Known immediate or delayed hypersensitivity to HSV.
  • Previous malignancy within 5 years before study entry.
  • Active or history of autoimmune disease.
  • Use of systemic immunosuppressive medication above specified doses within 14 days before study treatment, except limited topical or inhaled corticosteroids.
  • Familial, social, or geographic conditions preventing protocol compliance.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

Loading map...

Research Team

J

Jing Huang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here